faced a lot of hurdles from the U.S. Food
and Drug Administration (FDA). However, after receiving approximately 45,000
adverse event reports between 2005 and
2012 associated with the devices’ failure,
the FDA has decided to crack down. Until now, AEDs only have required 510(k)
clearance, which is obtained under substantial equivalence. But the agency now
is moving toward a pre-market approval
process for the devices.

AEDs are portable, electronic medical devices that shock hearts back into
normal rhythm with electrical stimulation
when they sense potentially life-threatening cardiac arrhythmias. In addition to the
thousands of adverse events reported, the
FDA also reported dozens of manufacturer
recalls. The agency called the problems encountered in the devices“preventable and
correctable,” the most common issues involving the design and manufacture of the
devices and inadequate control of components purchased from other suppliers.

“Automated external defibrillators savelives,” said William Maisel, M.D., M.P.H.,deputy director of science and chief sci-entist at the FDA’s Center for Devicesand Radiological Health. “However, theagency is concerned about the number ofrecalls and manufacturing problems thathave been associated with these devicesand we’re committed to working withmanufacturers to address these issues.”According to Maisel, even for manu-facturers that would not be required toconduct clinical trials, the cost of comply-ing with the new regulations would riseto about $220,000 from about $5,000. Hesaid that companies with multiple modelswould have to pay that money only once,and that the sum also could be applied tosubsequent versions.

While the FDA is launching a classification period to review AEDs, allowing
it to more closely monitor how the devices
are designed and manufactured, the agency
will not limit access to AEDs immediately, as
their evaluated benefits outweigh their risks.

The recently enacted Food and DrugAdministration Safety and InnovationAct calls for the FDA to publish a pro-posed and final order to reclassify or callfor PMAs for “pre-amendment” devices.AEDs were given a Class III designationwhen they were determined to be sub-stantially equivalent to similar Class III de-vices that were on the market prior to themanufacturers must submit to the FDAany significant manufacturing changesmade to the devices as well as annual re-ports of the device’s performance.

A typical AED unit found in public spaces. Image courtesy of CPR Savers & First Aid Supply LLC.

1976 Medical Device Amendments. After
a series of meetings in 2011 to discuss
which regulatory pathways is more appropriate to provide reasonable assurances
of safety and effectiveness for AEDs, the
FDA’s Circulatory System Devices Panel
recommended that AEDs remain Class III
medical devices and require PMAs.

PMA applications are required to con-tain clinical data to support a product’sapproval. However, added Maisel, “If ourproposed order is finalized, the FDA in-tends to focus its review of the pre-marketapplications on the more problematic as-pects of AEDs.”In addition to the clinical safety andeffectiveness data, a PMA also must in-clude a review of a manufacturer’s qualitysystems information and an inspection ofits manufacturing facilities. After approval,experts that this order from the FDA willcause the public to be more reluctant to usean AED when needed.“People already havea lack of comfort in using these devices,”Gordon Tomaselli, M.D., chief of cardiologyat Johns Hopkins University in Baltimore,Md., and a past president of the AmericanHeart Association, told The New York Times.“If word is out there that they don’t workanyway, people will be even more reluctantto do something that they were pretty ner-vous about to begin with.”The FDA will accept public commenton the proposed order until June 22. If theorder is finalized, the agency intends toexercise enforcement discretion for thosemanufacturers that notify the FDA of theirintent to file a PMA in a timely manner.The FDA intends to exercise enforcementdiscretion for 18 months. v